Sabitha Ananthi, D (2021) Formulation and Evaluation OF Modified Release Oral Solid Dosage Form (MR-OSDF) of Vildagliptin using Carbopol 71G-NF Polymer for the Treatment of Type-2 Diabetes Mellitus. Masters thesis, College of Pharmacy, Madurai Medical College, Madurai.
Full text not available from this repository.Abstract
The attempts have been made in our present research work in formulating the sustained release tablets of Vildagliptin for the management of Type 2 Diabetes mellitus by using two polymers such as Carbopol 71G-NF and Eudragit RS 100 at varying concentrations. The work has been summarized as follows: ❖ The half-life of Vildagliptin was found to be 1.32-2.43 hrs and its daily dose recommendation is 100 mg, in order to sustained its action for 12 hrs a day the sustained release tablets of Vildagliptin can be used to achieve its desired function. ❖ The λmax of Vildagliptin was found to be 205 nm in both acid and phosphate buffers. ❖ The Vildagliptin obeys the Beer’s law in the concentration range of of 5 – 25 μg/ml. ❖ The results of FT-IR interaction study revealed that there is no interaction between the drug and the polymers. ❖ The pre-compression parameters of all the formulations were within the acceptable limit and has good flow property. ❖ Tablets were compressed using mini rotary tablet press with 11-mm concave punches by direct compression technique. ❖ All the results of the post-compression parameters were within the acceptable limits. ❖ The in-vitro dissolution studies were performed for all formulations using Acid buffer pH 1.2 for the first two hrs and Phosphate buffer pH 6.8 upto 12 hrs. ❖ Based on the in-vitro release data, the formulations F2, F5 and F7 were selected as the best formulations. ❖ The equal ratio of both polymers Carbopol 71G-NF and Eudragit RS 100 (1:1) produce good drug release. ❖ The in-vitro dissolution data of all formulations were best fitted in the zero order and Korsmeyer-Peppas model with greater R2 value. ❖ The “n” values of Peppas model indicates that the drug release follows an anomalous transport mechanism. ❖ The in-vitro dissolution data were incorporated in DDSolver software and the kinetic models obtained were compared with that of the results obtained from excel sheet. ❖ Small variations of the R2 values and n values ranges from 0.01 to 0.1 in all the three best formulations were observed between the DDSolver and the excel sheet. CONCLUSION: This work reveals that the drug release rate of Vildagliptin SR tablets could be prolonged and sustained depending on the amount of polymers used. The drug release data of all formulations showed a good fit to Korsmeyer-Peppas equation indicating, a combined effect of diffusion and erosion mechanism. In addition when Carbopol 71G-NF was used in combination with Eudragit RS 100 the release of the drug was slower than the formulations containing Carbopol 71G-NF or Eudragit RS 100 alone at the same total polymer concentration. The results obtained from the in-vitro dissolution studies were incorporated and compared in both excel sheet and DDSolver. Small variations of the R2 values and “n” values were noted but there was no change in kinetic pattern which necessitates the use of PK/PD software in future to get accurate results.
| Item Type: | Thesis (Masters) |
|---|---|
| Additional Information: | 261911307 |
| Uncontrolled Keywords: | Formulation, Evaluation, Modified Release Oral Solid Dosage Form (MR-OSDF), Vildagliptin, Carbopol 71G-NF Polymer, Treatment, Type-2 Diabetes Mellitus. |
| Subjects: | PHARMACY > Pharmaceutics |
| Depositing User: | Ramakrishnan J |
| Date Deposited: | 15 Aug 2022 06:30 |
| Last Modified: | 18 Aug 2022 08:55 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/20779 |
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